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CompletedNCT06632002Updated Aug 20, 2026

Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes Who Require Nutritional Support

An interventional study of DSF1 and DSF2 in Diabetes, sponsored by Abbott Nutrition. Completed at 1 site in Taiwan. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Abbott Nutrition · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
21 Years to 90 Years
Sex
All
01

Study summary

The study aims to demonstrate the non-inferiority of diabetes-specific formula (DSF)1 compared to DSF2 in individuals with type 1 diabetes, type 2 diabetes or prediabetes and who are at nutritional risk.

Read the detailed description

This is a randomized, double-blind, parallel, non-inferiority study. Eligible participants will be randomly allocated (at 1:1 ratio) to one of two groups: DSF1 (experimental group) or DSF2 (control group). Both groups will incorporate one serving of the DSF into their daily diet, in addition to receiving standard of care for diabetes. The total expected duration of the study is up to 104 days, including a run-in period of up to 14 days, followed by an intervention period of 90 days. At Day 1, participants will be randomized into one of the two groups (n = 50 per group): DSF1 or DSF2. Participants will start the intervention on Day 1 and complete the intervention on Day 90.

02

Conditions studied

  • Diabetes

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03

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Has any of the following types of diabetes:

    1. Type 1 diabetes
    2. Type 2 diabetes
    3. Prediabetes
  2. Has MNA-SF score of ≤ 11
  3. Serum albumin less than 4.0 g/dL
  4. Energy or protein intake less than recommended
  5. BMI less than 30.0 kg/m2
  6. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the study
  7. Female of childbearing potential to use an effective method of birth control
  8. Chronic medication type and dose to be constant and maintained throughout the study
  9. Willing to follow the protocol throughout the study
  10. At least a two-week washout period between the completion of a previous research study and start in current study
  11. Willing to refrain from taking non-study diabetes-specific formula over the course of the study.

Exclusion criteria

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

  1. Has a screening HbA1c level less than 5.0% or ≥ 10%
  2. Has a current infection, inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or received antibiotics in the last 3 weeks
  3. Has active malignancy within the last 5 years
  4. Has significant cardiovascular event within 6 months prior to the study or history of congestive heart failure
  5. Has end-stage organ failure or is post-organ transplant
  6. Has current or history of renal disease or on dialysis or severe gastroparesis
  7. Has current hepatic disease
  8. Has a recent acute infection, physiologic stress or trauma within 1 month prior to the study
  9. Has had bariatric surgery including gastric balloon; history of gastrointestinal disease or intestinal surgery that can interfere with consumption or digestion or absorption of study product
  10. Has a chronic, contagious, infectious disease
  11. Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study procedures
  12. Taking any herbals, dietary supplements or medications during the past 4 weeks prior to the study
  13. Using diabetes-specific formula(s) or oral nutritional supplement formula(s) in more than one eating occasion per week within the past 3 months
  14. Has clotting or bleeding disorders
  15. Has blood or blood-related diseases
  16. Has received blood transfusion within the last 3 weeks
  17. Has allergy or intolerance to the study product
  18. Anticipated poor compliance to the study as assessed by the Investigator
  19. Participates in another study that has not been approved as a concomitant study by Abbott Nutrition
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    Experimental Product

    Other: DSF1 · Other: Standard of Care (SOC)

  • Other
    Control Product

    Other: DSF2 · Other: Standard of Care (SOC)

Interventions

  • OtherDSF1

    220 mL

  • OtherDSF2

    220 mL

  • OtherStandard of Care (SOC)

    Standard of care

05

What researchers measure

Primary outcomes

  1. Serum albumin

    Change in serum albumin levels from baseline to Day 90

    Time frame: Study Day 1 to Day 90

Secondary outcomes

  1. Serum albumin

    Serum albumin levels

    Time frame: Study Days 45 and 90

  2. Malnutrition risk

    Mini Nutritional Assessment - Short Form (MNA®-SF) a validated screening tool for identifying elderly persons who are at risk for malnutrition, or who are already malnourished. It classifies participants into one of three categories: 1. Normal nutritional status/score =12 to 14 points, 2. At risk of malnutrition/score = 8 to 11 points, 3. Malnourished/score = 0 to 7 points. Minimum point = 0, Maximum points = 14. Lower score indicates worse outcome, i.e., at risk of malnutrition or malnourished.

    Time frame: Study Days 45 and 90

  3. Malnutrition risk

    Malnutrition Universal Screening Tool (MUST) is a widely used screening tool for malnutrition. It classifies participants into one of three nutrition status categories: 1. Low risk/score = 0, 2. Medium risk/score = 1, 3. High risk/score ≥ 2. Minimum value = 0, Maximum value = 6. Higher score indicates worse outcome, i.e., increased risk of malnutrition.

    Time frame: Study Days 45 and 90

  4. Serum prealbumin

    Serum prealbumin levels

    Time frame: Study Days 45 and 90

  5. Body weight

    Body weight measured in kg

    Time frame: Study Days 45 and 90

  6. Body mass index (BMI)

    Calculated as weight (kg)/height (m)2

    Time frame: Study Days 45 and 90

  7. Mid arm circumference

    Mid arm circumference measured in cm

    Time frame: Study Days 45 and 90

  8. Mid arm muscle circumference

    Mid arm muscle circumference measured in cm

    Time frame: Study Days 45 and 90

  9. Triceps skinfold thickness

    Triceps skinfold thickness measured in mm

    Time frame: Study Days 45 and 90

  10. Calf circumference

    Calf circumference measured in cm

    Time frame: Study Days 45 and 90

  11. Waist circumference

    Waist circumference measured in cm

    Time frame: Study Days 45 and 90

  12. Hip circumference

    Hip circumference measured in cm

    Time frame: Study Days 45 and 90

  13. Waist-to-hip-ratio

    Waist-to-hip-ratio

    Time frame: Study Days 45 and 90

  14. Hemoglobin A1c (HbA1c)

    HbA1c levels

    Time frame: Study Days 45 and 90

  15. Fasting plasma glucose

    Fasting plasma glucose levels

    Time frame: Study Days 45 and 90

  16. 2-hour postprandial glucose

    2-hour postprandial glucose levels

    Time frame: Study Days 45 and 90

  17. Glycated albumin

    Glycated albumin levels

    Time frame: Study Days 45 and 90

  18. Triglycerides

    Triglycerides levels

    Time frame: Study Days 45 and 90

  19. High density lipoprotein (HDL) cholesterol

    HDL cholesterol levels

    Time frame: Study Days 45 and 90

  20. Low density lipoprotein (LDL) cholesterol

    LDL cholesterol levels

    Time frame: Study Days 45 and 90

Other outcomes

  1. Energy, macronutrient and micronutrient intakes

    A 3-day Dietary Record (two weekdays and one weekend day) will be completed by participant for the week prior Study Day 45 and 90 and evaluated by a dietitian. Nutrient analysis will be performed using a dietary analysis program.

    Time frame: Study Days 45 and 90

  2. Energy, macronutrient and micronutrient adequacy

    Nutrient adequacy will be determined by comparing nutrient intakes (outcome No. 21) against sex- and age- specific local recommended nutrient intakes (RNI).

    Time frame: Study Days 45 and 90

  3. Product intake compliance

    Compliance to study product prescribed over 90-day intervention period

    Time frame: Study Days 90

  4. Adverse events

    Reported adverse events for assessment of safety and tolerability

    Time frame: Study Day 1 to Day 90

06

Study locations

1 site
  • Chung Shan Medical University
    Taichung, 40201, Taiwan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06632002
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Oct 8, 2024
Start date
Jan 14, 2025
Primary completion
May 7, 2026
Completion
May 7, 2026
Last update
Aug 20, 2026

Study contacts

Mandy Yen Ling Ow, PhD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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